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Chemical Name: Tert-butyl (R)-(1-hydroxy-3-(4-iodophenyl)propan-2-yl)carbamate
Shipping Temperature: Ambient
HSN Code: 38229010
Country of Origin: India
Smiles: IC1=CC=C(C[C@@H](NC(OC(C)(C)C)=O)CO)C=C1
A liquid chromatographic method for separation of sacubitril–valsartan and their stereoisomeric impuritiesLu Zhou, Liang Zou, Lili Sun, Hui Zhang, Wenkai Hui and Qiaogen ZouAnal. Methods, 2018,10, 1046-1053 Quantification of potential genotoxic impurity in sacubitril/valsartan drug substance at ppm level by LC-MS/MSRavi Uppala, M.Arthanareeswari, S.Devikala,T.Pushpamalini, J. ArockiaSelviMaterials Today: Proceedings Volume 14, Part 2, 2019, Pages 640-645 Experimental Design Approach in HPLC Method Development: Application for the Simultaneous Determination of Sacubitril and Valsartan in Presence of Their Impurities and Investigation of Degradation KineticsBahia A. Moussa, Hanaa M. A. Hashem, Marianne A. Mahrouse & Sally T. MahmoudChromatographia volume 81, pages139–156(2018) Development and validation of a stability indicating UHPLC method for Sacubitril/Valsartan complex in the presence of impurities and degradation productsPintu Prajapati, Dhara Bhayani, Priti Mehta.J App Pharm Sci. 2020; 10(2): 97-107
Sacubitril Impurity 91 is chemically Tert-butyl (R)-(1-hydroxy-3-(4-iodophenyl)propan-2-yl)carbamate. Sacubitril Impurity 91 is supplied with detailed characterization data compliant with regulatory guideline. Sacubitril Impurity 91 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Sacubitril.
The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.
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